Monocentric Phase 1 Study With Escalation of Doses of Toc... | NCT04547062

ID	Type	Description	Link
2020-003209-77	EudraCT Number

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 29, 2020Actual

Primary Completion Date

Apr 4, 2023Actual

Completion Date

Apr 4, 2023Actual

First Submitted Date

Sep 4, 2020

First Submission Date that Met QC Criteria

Sep 4, 2020

First Posted Date

Sep 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2023

Last Update Posted Date

Apr 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a phase 1 dose escalation study testing the addition of an anti-IL6 (tocilizumab) to standard induction chemotherapy for high-risk AML.

Detailed Description

Administration of tocilizumab at day 8 of induction following a classical induction using idarubicin 8mg/m2/d for 5 days and cytarabine 100mg/m2/d for 7 days.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Name	Type	Description	Arm Group Labels	Other Names
Tocilizumab	Drug	Administration of tocilizumab at day 8 of induction following a classical induction

Measure	Description	Time Frame
number of DLT		45 days

Measure	Description	Time Frame
Number of response		25 months
Percentage of medullary blaste		24 months
number of days of neutrophil recovery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- AML with a poor prognosis defined according to the criteria below: LAM First line: Age <60 years and unfavorable risk according to the 2017 ELN Age> = 60 years old and intermediate or unfavorable risk according to the ELN 2017 LAM in Relapse: whatever the age

ECOG <= 2
Patient eligible for intensive chemotherapy
Informed consent
Liver function tests: transaminases <3x normal, bilirubin <1.5X normal
Creatinine clearance> 60ml / min
LVEF> = 50%

Exclusion Criteria:

Uncontrolled infection
Hep B, C, HIV +
History of diverticulosis / diverticulitis
No social security or any other scheme
Pregnant women or patient unable to take contraception(contraceptive pill, abstinence, IUD unauthorized) in case of fertility. A patient who cannot continue contraception for at least 3 months after the last injection of TOCILIZUMAB is not eligible.
Lactating women
Minors
Adults under guardianship, curatorship or legal protection
Hypersensitivity to one of the active substances or to one of the excipients
Patients with tuberculosis
Patients documented with active COVID

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CHU of Nantes		Nantes		44093	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37786451	Derived	Peterlin P, Garnier A, Le Bourgeois A, Guillaume T, Le Bris Y, Theisen O, Bene MC, Eveillard M, Rimbert M, Jullien M, Planche L, Gaschet J, Chevallier P. Tocilizumab in combination with a standard induction chemotherapy in acute myeloid leukaemia patients (TOCILAM study): a single-centre, single-arm, phase 1 trial. EClinicalMedicine. 2023 Sep 28;64:102254. doi: 10.1016/j.eclinm.2023.102254. eCollection 2023 Oct.

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases